The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.

standard endovascular coil embolization with or without adjunct techniques

Other Names:

platinum coil

hydrogel coil

Active Comparator: 2

hydrogel coils

Procedure: endovascular coil embolization

standard endovascular coil embolization with or without adjunct techniques

Other Names:

platinum coil

hydrogel coil

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

All patients presenting at least one aneurysm 'prone to recurrence after endovascular treatment' (PRET), defined for the sake of this study as:

PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms); for ruptured lesions, patients should be in WFNS grade I, II or III.

PRET-2: an Aneurysm presenting a major recurrence after previous coiling; and judged by the neurovascular team to require elective treatment.

The anatomy of the lesion is such that endovascular treatment is possible with both types of coils (not necessarily certain or probable)

The endovascular physician is content to use either type of coils (platinum or hydrogel-coated coils) but no other type of coils

Patient is 18 or older

Life expectancy is more than 2 years

Exclusion Criteria:

Presence of other aneurysms requiring treatment during the same session

Patients with associated cerebral arteriovenous malformations

When parent vessel occlusion, without simultaneous endosaccular coiling of the aneurysm, is the primary intent of the procedure

Any absolute contraindication to endovascular treatment, angiography, or anaesthesia such as severe allergies to contrast or medications

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626912